Your Local Conference Co-Sponsored by the

FDA Los Angeles District

Learn Regulatory Best Practices in FDA Regulated Industries

from Industry Experts and Regulators

Medical Devices/IVDs

Drugs and Biologics

Dietary Supplements

Clinical Trials

It only happens once a year!

Featuring a Cinco De Mayo appetizer spread

We hope to see you in May.

19th Annual

The Emerging Regulatory Landscape

Orange County Regulatory Affairs and FDA Los Angeles District

FDA-OCRA Educational ConferenceMay 5-6, 2016 NEW LOCATION Westin South Coast Plaza

http://www.ocra-dg.org/

SPEAKERS MODERATOR SYNOPSIS

7:00-8:00 AM Registration and Continental Breakfast

8:00-8:30 AM Opening Remarks

Evelyn De La Vega, Sr. Manager, Regulatory Affairs, Bausch + Lomb

Steven Porter, Director, FDA Los Angeles District

Kimberly Ricks, Manager, Health Science Information, Herbalife

8:30-9:15 AMFDA Keynote Presentation: CDRH Update and Strategic Plans for 2016

William Maisel, MD, MPH, Deputy Director of Science and Chief CDRH Scientist, FDA (remote presentation)

Ray Brullo, DPM, Compliance Officer, FDA Los Angeles District

William H. Maisel, MD, MPH is Chief Scientist and Deputy Center Director for Science at FDA’s Center for Devices and Radiological Health (CDRH). He is responsible for providing leadership in the development, implementation, execution, management and direction of the Center’s broad national and international biomedical science programs.

Prior to joining FDA, Dr. Maisel was Associate Professor of Medicine at Harvard Medical School with more than 15 years of clinical experience as a Board-certified cardiologist.

He is former Chair of the FDA Circulatory System Medical Device Advisory Committee and is a former member of the Center for Medicare and Medicaid Services Coverage Advisory Committee. Dr. Maisel received his undergraduate degree in biology from MIT, his medical degree from Cornell Medical College, and his Masters in Public Health from the Harvard School of Public Health. He has published more than 120 research manuscripts, book chapters, and scientific abstracts on regulatory science, device innovation, and medical device safety and effectiveness.

9:15-9:30 AM Break

FIRST DAY - Thursday, May 5, 2016

May 5-6, 2016 at The Westin South Coast Plaza, 686 Anton Blvd., Costa Mesa, CA 92626

19th Annual FDA-OCRA Educational Conference: The Emerging Regulatory Landscape

Conference Chair: Kimberly Ricks, Manager, Health Science Information, Herbalife International)

Introductions and Keynote Presentation in Plaza Ballroom

9:30-10:30 AMPlenary Session #1Fast Track Approvals for Drugs and Devices

Michael A. Swit, Esq., Senior Director, Legal, Regulatory, Illumina, Inc.

Trudy Papson, President, Regulatory Consultants Group (former FDA Investigator)

In tackling the challenge of developing a drug or device for FDA approval, a common assumption is that the effort will take years and cost the budget of a small city. And, then, when you file at FDA, you worry that you will have to wait forever for a decision. While there is some truth in that hyperbole, the reality is that there are a number of programs available at FDA that are designed to speed the development and approval process. In this session, we will explore those mechanisms for both drug (and biologic) and device (including diagnostics) products.

Ranging from the “breakthrough drug” provisions of the 2012 Food & Drug Administration Safety and Innovation Act (FDASIA) to the protocol assistance requirements of the 1983 Orphan Drug Act to the Special 510(k) process, we will review how to qualify for these programs, their benefits, and their burdens, all with aim of helping you, where possible, get your product to the market faster while still satisfying the legal requirements for approval.

10:30-11:30 AM

Plenary Session #2Due Diligence: The Regulatory, Quality, and Clinical Challenges Posed by Transactions Involving Highly-Regulated Biotech Products and Companies

Sally Maher, VP Clinical & Regulatory Affairs, Edwards Lifesciences

Michael A. Swit, Esq., Senior Director, Legal, Regulatory, Illumina, Inc.

How to handle the difficult scientific and legal issues underlying the regulatory clinical and quality aspects of due diligence involving biotech products and companies.

Transactions involving FDA-regulated firms or products present unique challenges for professionals less familiar with the intricate regulatory, quality, and clinical considerations generated by the deal. This session will explore how to prepare and execute due diligence efforts , including how to separate the essential from the “nice-to-know” in conducting such reviews often with limited resources and subject to tight time lines. Attendees also will hear about other key issues involved in due diligence and learn how to organize internal teams so as to maximize efforts to help management decide if a deal is “GO!” or “no go.”

Plenary Sessions in Plaza Ballroom - Thursday, May 5, 2016

11:30 AM-12:30 PM

Plenary Session #3Supply Chain Security Case Study and Panel Discussion

Amanda Bettinelli, Assistant United States Attorney, US States Attorney's Office, US Department of Justice

Ray Brullo, DPM, Compliance Officer, FDA Los Angeles District

Tracy Hughes, Deputy District Attorney, County of Orange

Tom Sidebottom, Laboratory Director, FDA San Francisco District

Dan Solis, Director of Import Operations, FDA Los Angeles District

Kim Walker, MS, RAC, Global RA and QA Consultant, Kim Walker Consulting

Government officials will participate in two case study panel discussions.

Introductions· Each speaker will introduce themselves· Tell a little about what they (in their roles) do to protect the public health· Tell us how/if they interact with industry· What they would like to see industry do better· What they think FDA or their office should do better· How FDA/or their office and Industry can collaborate to protect the public health more effectively

Case Study #1 – Cosmetic Contact Lenses· Overview presented by Amanda Bettinelli· How this case was identified through the import and inspection process· How the FDA laboratory evaluated the device samples collected· How this case is representative of many device, pharma, and dietary supplement supply chain issues· The role of FDA’s Quality Program in this case· How details about this case are made available through press releases and FOI requests

Case Study #2 – Dietary Supplements· Overview presented by Tracy Hughes· How this case was identified through the import and inspection process· How the FDA laboratory evaluated the samples collected · How this case is representative of many device, pharma, and dietary supplement supply chain issues · The role of FDA’s Quality Program in this case · How details about this case are made available through press releases and FOI requests

Q&A with Audience12:30-1:30 PM Lunch

1:30-2:30 PM

Clinical Trials Session #1Next Generation of Trial Design and FDA Regulations on Personalized Medicine

Razelle Kurzrock, MD, Senior Deputy Center Director, Clinical Science Director, Center for Personalized Cancer Therapy, UC San Diego Moores Cancer Center

You Li, PhD, Scientific Reviewer, Division of Molecular Genetics and Pathology, Office of In vitro Diagnostics and Radiological Health, CDRH, FDA

Lei Zhang, PhD, Global Executive Director, Clinical Development, Zensun USA, Inc.

Dr. Kurrzrock will discuss "Precision Medicine and Next Generation Trial Design:Implications of Biomarkers for Predicting Response and Toxicity"

Precision cancer medicine entails tailoring therapy to the distinct and complex molecular portfolio of each patient and their tumor. Its execution is being enabled by disruptive technological innovations with the rapid emergence of sophisticated "omic" platforms, as well as the increasing availability of compounds that precisely target genomic defects and/or the immune system.

Our recent results show that, amongst 439 patients with metastatic solid cancers, 98.4% were molecular singletons (malignant “snowflakes”), reflecting the inimitability of advanced tumors. Similarly, the host is also complex and unique, a fact that is key to understanding immune responsiveness and susceptibility to toxicity.

In light of these observations, the canonical paradigms for clinical research/practice are a poor fit for the complicated reality that genomics has unveiled. Traditional modes of clinical research/practice are drug centered, with a tactic of identifying commonalities between patients so that they can be grouped together and treated similarly. However, if each patient with metastatic cancer has a unique molecular fingerprint, a new patient-centered approach that deploys individually customized, combination therapy is required.

Herein we will discuss the following strategies for optimization of precision medicine in cancer:1. Fully interrogate the omic underpinnings of both the patient and their tumor.2. Provide individually tailored, combination therapy to patients with complex molecular landscapes.3. Apply the principles of precision medicine earlier in the disease course, preferably at the time of diagnosis, before the tumor has had a chance to evolve and metastasize.4. Move from a drug-centered to a patient-centered, N-of-one treatment approach.

You Li, PhD will present "Regulation of Molecular Dx Devices for Personalized Medicine"

As part of the Precision Medicine Initiative (PMI), FDA is actively engaged to develop a regulatory pathway to advance innovation in precision medicine and protect public health with sufficiently flexible standards to assess performance of In vitro diagnostic Devices. This talk will provide a summary on Molecular Dx devices for personalized medicine, key components to evaluate during Molecular Dx device submission review and a brief update PMI and Precision FDA.

2:30 - 2:45 PM Ice Cream Break

Clinical Trials Breakout Sessions in Santa Ana/Costa Mesa Rooms - Thursday, May 5, 2016 (Session Chair: Lei Zhang, PhD, Global Executive Director, Clinical Development, Zensun USA, Inc.)

2:45-4:00 PMClinical Trials Session #2Clinical Quality System, and Data Integrity

Greg Bennett, MSEd, Director, Global Clinical Operations, Transcend Medical, Inc.

Larry Shen, PhD, pStat®, Senior Statistical Advisor, President & CEO, Pharmapace, Inc.

Ginger Clasby, VP - Clinical & Regulatory Affairs/Quality Assurance, Transcend Medical, Inc.

Greg Bennett's presentation is "Clinical Quality System and its Ulitlity for Clinical Trial Management."

Close monitoring and management of clinical trials from the beginning to end a key component of success. A strong quality system to oversee the monitoring and management of the clinical trial is a vital factor for ensuring the strength of the trail. The prospective approach to quality increases the utility of the entire trial. Quality site selection, robust training for site staff, eligibility review and approval prior to enrollment, study coordinator support, monitoring process oversight, and close data review provide the foundation for data integrity and good inspection outcomes. The presentation will address one company’s clinical quality system that resulted in excellent inspection outcomes for data integrity and clinical study records.

Dr. Shen's presentation will be on "How to Prevent Rescue of Data and Analyses in Your Clinical Trials."

In this presentation Dr. Shen will share some of his observations of quality issues associated with data and analyses in drug development programs. It is well known that the most expensive step in drug development is usually to conduct human experiments in the form of clinical trials to collect efficacy and safety information. This step often costs hundreds of million dollars and is associated with a high failure rate. The end product of this step is clinical data that can be analyzed to draw conclusions about safety and efficacy of the drug candidates, for submissions to regulatory agencies for market authorization, and for writing prescription information.

There have been numerous examples that sponsors choose to cut corners in order to save costs, which had led to poor data quality and inferior statistical analyses that resulted in wrong conclusions, or inclusions in many cases. It often costs more and incur delays to rescue these projects. He will provide some examples and address the right approaches to data and analysis quality to prevent the need for rescue.

4:00-5:15 PM

Clinical Trials Session #3EU Clinical Trials:New Regulations and Operations

Helene Lamielle, MD, MBA, Executive Strategic Consultant, HLaConsulting

Karen Hill, Senior Vice President, Global Therapeutic Leader, Cardiovascular & Late Phase, Worldwide Clinical Trials

Kim Walker, MS, RAC, Global RA and QA Consultant, Kim Walker Consulting

Dr. Lamielle will present "How ICH Guidelines and EU Regulation Changes Will Affect Clinical Trials"

Critical to the introduction of safe and effective new products to the market, the Clinical Study field is now under significant changes internationally, with increased requirements, scrutiny and enforcement from regulatory bodies.

We will discuss when and how the new EU Clinical Trial Regulation 536/2014 and the upcoming revision of ICH E6 are impacting our practice, and how to plan for synergies in addressing evolving global GCP standards and expectations.

Karen Hill will present "Practical Considerations to Execute Clinical Trials in Europe to Support FDA Submissions"

On April 28, 2008, the FDA amended its regulations on the acceptance of foreign clinical studies not conducted under an IND as support for a “marketing application”. The final rule requires such studies be conducted in accordance with GCP, including review and approval by an independent ethics committee and informed consent from subjects.

But how practical is this to implement and what exactly is required?

Using a case study you will learn how foreign clinical data obtained from Europe, especially Eastern Europe, can support clinical investigations and marketing approvals in the US; and how some sponsors even seek to rely exclusively on foreign clinical data to support their INDs. The trend is that the number of INDs and applications for marketing approvals supported by foreign clinical trials has increased in recent years and will likely continue to increase in the future.

Although clinical research is becoming global, it presents challenges to the US regulators. Restrictions limit the number of foreign clinical site inspections that can be conducted, so how can we make our EU data matter? Some practical considerations will be shared with audience.

1:30-2:45 PM

Dietary Supplement Session #1FDA Health Fraud and Botanical Adulteration Presentations followed by Dietary Supplement Panel Discussion with Industry Experts

CDR Jason Humbert, Health Fraud, Office of Regulatory Affairs, FDA (remote presentation)

Nora Dowell, Vice President, Quality and Regulatory Affairs, International Vitamin Corporation

Debra K.W. Topham, MS, CNS, CFS, Director, knowledge bank

Talash Anne Likimani, PhD, Sr. Director Regulatory Affairs, Arbonne

Virginia Hill, RAC, Director, Regulatory Affairs, Pharmavite LLC

The session will begin with a presentation on Health Fraud by the FDA.

Nora Dowell will present Botanical Adulteration

Following these presentations, a panel will answer these key questions for the industry. 1. What are the most overlooked elements of study design to support supplement claims?2. How do you market products to consumers who don’t know much of anything about science?3. How do you integrate supplement products into a wellness program?4. What needs to change in current regulation for supplements to deliver more value to consumers?5. What would immediately change if pre-market approval of supplement products were legislated?6. Is there any room for first-amendment arguments to open the market to more aggressive supplement claims?7. Effects of proposed Nutrition Facts panel changes to SF panels (fiber and Vitamin E examples)8. Certified Paleo - wishful thinking for the supplement industry9. Serving sizes - what is an eating occasion

2:45-3:00 PM Ice Cream Break

3:00-4:15 PMDietary Supplement Session #2Interactive Workshop: Hands on Claims/Benefits

Katie Bond, Attorney and Senior Associate, Kelley Drye

Cameron Smith, Senior Director, Counsel, Herbalife

Cameron Smith, Senior Director, Counsel, Herbalife

Teams will be tasked to work up draft claims/benefits language after reviewing some hypothetical facts. We will work on two separate products.

4:15-5:15 PMDietary Supplement Session #3Alternative Pathways for Regulation

Cameron Smith, Senior Director, Counsel, Herbalife

Cameron Smith, Senior Director, Counsel, Herbalife

A critical examination of the EFSA claims assessment model and the Canada NHP regulatory model as ways to improve the quality or value of supplements to the end consumer.

5:30-8:00 PM

Dietary Supplement Breakout Sessions In Balboa Room - Thursday, May 5, 2016 (Session Chair: Cameron Smith, Senior Director, Counsel, Herbalife)

Attendees Invited to a separate event, OCRA's Member Appreciation Night with OCRA Members serving Appetizers and Drinks

7:00-8:00 AM Continental Breakfast

8:00-9:15 AM

Medical Device Session #1Changes in EU Medical Device Regulation: The Notified Body Perspective

Peter Havel, PhD, Senior Vice President, MHS Global and Regional Director MHS, TÜV SÜD America Inc.

Tammy Vu, RAC, Senior Regulatory Affairs Specialist, Abbott Medical Optics Inc. (AMO)

Regulatory experts need to be prepared as early as possible for the upcoming regulation changes in Europe. The message was clear - change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. Learn about the status of the current discussions and the remaining regulatory options in the EU Commission, Parliament and Council in anticipation of a possible final decision in 2016. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. Contribute to discussions on the status of preparations in the industry and within Notified Bodies, the impact of these changes and how to make relevant decisions.

9:15-10:30 AM Medical Device Session #22016 Changes to ISO 13485

John Bis, VP Healthcare Solutions, BSI Group America

James R. Lusk, RAC, Principal, Quality Systems International (QSI)

Do you know that major changes are coming to ISO 13485? Should we also expect subsequent adoption by the European Union (EN ISO…). What about new requirements and more procedures? There are more. This session will provide you with the current status of the changes, the major changes, how to revise the Quality System to support the changes, and with a lot of hope, help you to revise your Quality System two minutes before it must be done.

10:30-10:45 AM Break

10:45-NoonMedical Device Session #3Cybersecurity Threats in the Medical Device World

Marcel Hill, Global Director, IoT Services, Intertek

Seth Carmody, Staff Fellow, CDRH, Emergency Preparedness/Operations & Medical Countermeasures, FDA (remote presentation)

Shep Bentley, RAC, President, Bentley Biomedical Consulting, LLC

Paul Kramsky, President, Rockin' Regulatory, Inc.

With the increased use of wireless technology and software, medical devices that are connected to the Internet, hospital networks, and to other medical devices are becoming more vulnerable to cybersecurity breaches, potentially impacting the safety and effectiveness of these devices. The threat is real, as evidenced by a number of recent instances, such as the hacking of implantable insulin pumps reported in 2011, the temporary closure of a Veteran’s Administration Catheter Lab in 2014 caused by malware infected computers used in cardiac procedures, and more recently, confirmation of the potential for remote access of Hospira infusion systems through a hospital’s network.

Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them, and this can be especially challenging. As part of its ongoing efforts to protect the public health from cybersecurity vulnerabilities and maintain a balance of protecting patient safety while using innovative technologies, the FDA held a public workshop in October 2014 to seek input from the health care and public health sector on medical device and health care cybersecurity. Very shortly after this workshop, FDA held a webinar and issued two guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software. This program, featuring experts from both FDA and industry, will report on the latest developments in the cybersecurity of medical devices and provide manufacturers with steps they can take to proactively support the safety and effectiveness of their medical devices in this bold new cyber world.

The FDA speaker will speak on Comprehensive Cyber Security Risk Management: Know, Assess, Fix

SECOND DAY - Friday, May 6, 2016

Medical Device Breakout Sessions in Costa Mesa Room - Friday, May 6, 2016 (Session Chair: Chris Posin, RAC, Consultant)

19th Annual FDA-OCRA Educational ConferenceMay 5-6, 2016 at The Westin South Coast Plaza, 686 Anton Blvd., Costa Mesa, CA 92626

8:00-9:15 AMDrugs & Biologics Session #1Biologics and Quality by Design

Christopher Watts, Founding Partner, Volpal

Cindy Fisher, PhD, Director, Regulatory Affairs, Vical Incorporated

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9:15-10:30 AMDrugs & Biologics Session #2Quality Metrics in Pharmaceuticals

Cylia Chen, Sr. Manager, Amgen

Valerie Whelan, Executive Director, Quality Site Head, Thousand Oaks, Amgen

Amy Stanton, Quality Systems Specialist, Amgen

Quality metrics are widely used in the industry to monitor processes and quality control and many are collected and maintained as GMP documents. With the roll out of FDA’s new risk based inspection approach, the industry needs to implement a metrics program whereby data from FDA defined metrics will have to be reported to the agency. This session provides overview of the Quality Metrics draft guidance and industry’s comments submitted to FDA, including short term and long term challenges and benefits. The first half of this session will examine the application of statistical quality control techniques to ensure the quality of biological products. The second half will cover the applicability and incorporation of quality by design concepts in the management of development and risk in biologics manufacture.

10:30-10:45 AM Break

10:45-Noon Drugs & Biologics Session #3Smart Scale-Up Strategies

Rachel Novak, PhD, Fellow Inter Agency Oncology Task Force, FDA

Mehrshid Alai, PhD, Senior Vice President, Baxalta

Ruchika Raval, President, Global Biopharm Regulations Inc.

During the Drug Development Process, variations typically exist between early-phase clinical trial material and materials used in Phase III and subsequent market launch. Without a carefully developed scale-up plan, the materials may be so different from one another that the Agency asks the Sponsor to conduct a comparability study before launch, which adds delay and cost to the program. How can Regulatory and Development groups collaborate to reduce the burden? What are some key principals, methodologies, and best practices to minimize the risk?

Noon End of ConferenceOCRA (Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612. Contact Kimberly Syre with any questions: ksyre@cox.net or 949-387-9046

Drugs & Biologics Breakout Sessions in Santa Ana Room - Friday, May 6, 2016 (Session Chair: Cindy Fisher, PhD, Director, Regulatory Affairs, Vical Incorporated)

Step 1: Click on this link: http://www.ocra-dg.org/

Step 2: From the Home Page, enter your user name and password in the two empty fields to the right of the ocean graphic if you have an exist-ing account on our site. If you do not yet have an account, select “sign up” to create a new account. Immediately log in with your user name and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

If you do not know your user name or password, click on “Forgot login?” and follow the steps.

Step 3: Once you have logged on (and paid for membership) select the meeting you would like to attend (See Home Page near the bottom right side of the ocean graphic. Once on the page for the event, scroll to the bottom and click “Register Now!”. Complete the registration process by filling in the appropriate fields.

NON MEMBERSIf you are not an OCRA Member, we require you to join OCRA before registering for this meeting. To join OCRA go to this link: http://www.ocra-dg.org/. Once you have paid for membership, follow the instructions above to register.

MULTIPLE REGISTRATIONS:Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address. Supply a credit card number and expiration date or let us know that a check will be mailed (checks should be received prior to the event). If you need a receipt, please let us know to whom it should be emailed.

To Register With Company or Personal Check: Please submit the online registration form. Mail your check made payable to OCRA to the following address:

Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612Tel: 949-387-9046 Fax: 949-266-8461 Email: ksyre@cox.netOCRA’s non-profit Federal Tax ID# 33-0630455

Cancellation Deadline:For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by April 22, 2016.

NOTE: If you have reserved a space but do not attend, your payment MUST be remitted. We will ask for a credit card pay-ment for any checks not received by the meeting date.

Group Registrations: This conference is priced to break even, as such, we do not offer discounts for group registrations. Please com-plete the registration form for each attendee.

We also accept faxed registrations. See registration form on the next page.

Venue: The Westin South Coast Plaza686 Anton Blvd., Costa Mesa, CA 92626714-540-2500 - Free shuttle from John Wayne Airport (SNA)http://www.westinsouthcoastplaza.com/

Directions:From Los Angeles: Take 405 South, Exit at Bristol. Turn Left on Bristol, Right on Anton, Left on Park Center Dr. Hotel on the Left.From San Diego: Take 5 North to 405 North. Exit at Anton Blvd. Turn Left on Anton. Turn Right on Park Center Dr. Hotel on the Left.

RegistRation instRuctions

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference

Please Provide Complete Contact Information for Each Attendee:

FIRST NAME: LAST NAME:

COMPANY: TITLE:

ADDRESS:

CITY/STATE/ZIP:

PHONE: __________________________________________E-MAIL: _________________________________________________

Vegetarian Meal Requested or List Other Dietary Restrictions:

Please Select Your Breakout Sessions (you can switch sessions at the conference if needed):

May 5 _______Clinical Trial Breakout Sessions _______Dietary Supplements Breakout Sessions

May 6 _______Medical Device/IVD Breakout Sessions _______Drugs and Biologics Breakout Sessions

Registration Fee includes the following: Access to available speaker presentations to download prior to the conference (some will be sent after the conference, breakfast, lunch on first day, breaks and parking.

Please check type of card: ______Visa ______ Master Card ______ American Express

Card #: Exp Date:

Name on Card:

Signature: Name badges and receipts will be provided at the on-site registration desk. If you would like a receipt prior to the event, please use the On-Line or Pay Pal payment option.

Registration Rate_______$ 775 - OCRA Members_______$ 825 - Non-members (includes OCRA membership for one year)_______$ 475 – FDA/Government/Students* (rate not available for online registration, please fax this form)_______$ 475 - OCRA Members - Thursday - For Dietary Supplement Industry Attendees Only_______$ 525 - Non-members - Thursday - For Dietary Supplement Industry Attendees Only

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA. We do not offer online registration at this rate as it requires approval. Please fax this form with payment and items described above (if applicable).

**The one day rate is available for those attending the Dietary Supplements breakout.

RegistRation FoRm

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference

OCRA (Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612Contact Kimberly Syre with any questions: ksyre@cox.net or 949-387-9046

The Westin South Coast Plaza 686 Anton Blvd., Costa Mesa, CA 92626Free shuttle from John Wayne Airport (SNA)

http://www.westinsouthcoastplaza.com/

Driving Directions to Westin South Coast Plaza

From Los Angeles:Take 405 South,Exit at Bristol.Turn Left on Bristol.Turn Right on AntonTurn Left on Park Center Dr.Hotel will be on the Left.

From San Diego:Take 5 North to 405 North.Exit at Anton Blvd. Turn Left on Anton.Turn Right on Park Center Dr.Hotel will be on the Left.

It is recommended that you look up driving directions from your own starting point.

about the Venue

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference